Body fluid testing component for simultaneous analyte detection

ABSTRACT

An analyte testing device is provided for use with a mobile processing device having a camera with a lens, a processor for processing an image captured by the lens. The analyte testing device comprises a casing and a test strip positioner. The test strip positioner positions an analyte containing test strip adjacent to the camera lens to permit the camera to capture an image of the analyte containing test strip. A light source is disposed within the casing. The light source is positioned within the casing to illuminate the analyte containing test strip to facilitate the capture of the image of the test strip. Software is contained within the mobile processing device for performing a quantitative analysis of at least one analyte from the captured image, and providing an output of the results of the quantitative analysis.

PRIORITY CLAIM

The present application claims priority to and the benefits of Kloepfer,U.S. Provisional Patent Application No. 60/667,240 which was filed on 1Apr. 2005.

I. TECHNICAL FIELD OF THE INVENTION

The present invention relates to methods and devices for testinganalysis fluids, and more particularly to a device capable ofsimultaneously providing quantitative information about multiple testanalytes. In a preferred embodiment, the multi-analyte test device canbe coupled to or integrated with an existing processing device, such asa personal computer (PC), or a mobile processing device (“MPD”), such asa tablet PC, a mobile telephone, or a personal digital assistant.

II. BACKGROUND OF THE INVENTION

A. Trends in Healthcare. Traditional healthcare services have beenconcerned primarily with the treatment of disease. However, it isbecoming increasingly recognized by medical professionals that while thetreatment of disease will always be an important component ofhealthcare, the focus of healthcare should shift to the monitoring andmaintenance of a person's health prior to and during the onset of adisease. It is believed that healthcare expenses can be reduced, andquality of life can be increased by: (1) monitoring health conditionsprior to the onset of a disease, so that the disease can be treatedearlier; and (2) convincing people to change their lifestyles in waysthat reduce the likelihood of disease occurring.

Several medical conditions exist where the monitoring of levels ofparticular analytes in a person's blood stream are important. Forexample, the level of analytes such as cholesterol, glucose, and lactateare important parameters to monitor to gain an understanding of theperson's over-all health condition, and to provide vehicles for earlyintervention, when appropriate, to help treat disease conditions earlyafter their onset.

B. Glucose Monitoring and Diabetes. In the year 2000, 3.2 million peopledied from diabetes. A key to treating diabetes is maintainingappropriate glucose levels in the patient. Tight glucose control in aform of self-monitoring the blood glucose (SMBG) is considered to be thestandard of care for diabetes management and treatment.

C. Atherosclerosis and Cholesterol Levels. Coronary Artery Disease(“CAD”) caused by atherosclerosis is the leading cause of death in theWestern world, and is predicted to be the leading cause of death in thedeveloping world before 2025. In the U.S., over 50 million people arecandidates for drug and/or dietary treatment to modify the profiles oftheir lipids, such as their “good” and “bad” cholesterol. However, suchtreatments are enhanced if cholesterol levels are monitored.

D. Sports Medicine and Blood Lactate Levels. A growing interest hasdeveloped in recent years in measuring blood lactate levels, since bloodlactate serves as a marker of anaerobic glucose metabolism inover-trained muscles. Lactate levels are now routinely monitored by mostprofessional and many serious amateur runners, bicyclists, and swimmers,along with people participating in many fitness and wellness programs.

E. Products Available for Monitoring Glucose Levels. A wide variety ofproducts exist currently, that are useable by the consumer to monitorglucose levels. Currently products are available from Roche Diagnostics(ACCU-CHEK® products); Bayer® (ASCENSIA-brand products); Therasense®(Free-Style® brand products); and Lifescan® (ONE-TOUCH® brand products).

Typically, these products consist of stand-alone meters that are used inconnection with a blood test strip. To operate these meters, one employsa lancet device that punctures a tiny hole in a high-blood flow bodypart, such as a finger tip. A drop of blood is harvested from the hole,and placed onto a test strip. On the test strip, the cellular components(e.g. red and white blood cells) of the blood are separated from theplasma component. The plasma component may be reacted with one or morereagents that are embedded on this strip, to cause the reagents toundergo a chemical reaction, and form a reaction product. With manystrips, the reaction product is colored. The color can be correlated tothe level of glucose in the sample. The test strip is then “read” by themeter, usually by reflectance photometry.

F. Products Available for Monitoring Cholesterol Levels. Several homedevices also exist for measuring blood cholesterol levels. Some of thesedevices are operated similarly to the blood glucose level testingdevices described above. Examples of these include the Cardio Chek® andCardio Chek® professional devices, and the Life Stream®, Three MinuteCholesterol Monitor.

An alternative test methodology is illustrated with the CholesTrac homecholesterol test. The CholesTrac test is a manual system that does notemploy an electronic meter. Rather, the person using CholesTrac devicevisually compares the “color” of the reacted test analyte with acolorant-containing result chart to determine the cholesterol level.

G. Products Available for Monitoring Lactate Levels. Lactate measuringdevices also exist that are similar to the blood glucose and cholesterolmeter devices described above. Examples of these include the ACCU-TREND®Lactate and ACCUR-SPORT® portable analyzer, along with the Lactate Probebrand portable lactate analyzer. The devices operate similarly to theglucose and cholesterol meters, as a drop of blood is placed on areagent containing test strip, which is then inserted into a meter.

H. Blood Testing Devices Invented by the Applicants and TheirColleagues. The Applicants, along with their colleagues have inventedseveral devices that can be used in blood testing. These devices includethe capillary test strip to separate particulates shown in Hans G.Kloepfer et al., U.S. Pat. No. 6,696,240 (24 Feb. 2004); theConsolidated Body Fluid Testing Device and Method shown in Hans G.Kloepfer et al., U.S. Patent No. 2003/0109777 (12 Jun. 2003); and HansG. Kloepfer et al., Method and Apparatus for Analyzing an AnalysisFluid, U.S. Published Patent Application No. 2006/0034728, published 16Feb. 2006. See also Mary G. Kloepfer, U.S. Pat. No. 4,883,764 (28 Nov.1989).

The Kloepfer et al., '240 patent relates to a capillary strip that isused to separate particulates from whole blood. The Kloepfer deviceperforms the separation of particulate matter from plasma by employing agradient of capillary force to move the cell and plasma containing bloodsample from a sampling portion wherein the blood is deposited on thestrip, to a reagent containing testing site. After the blood has reachedthe reagent containing test site, the cellular components are removed,with only the reacting plasma remaining.

The Kloepfer et al., '777 publication discloses a device that includesall of the disposable blood testing components required to perform ablood test incorporated into a single, easy-to-manufacture unitarycomponent that can be manufactured inexpensively enough to make singleuse and disposal economically viable. The Kloepfer consolidated testingdevice includes a unitary body that carries a disinfectant containingswab, a calibratable and moveable lancet, a blood-flow enhancementdevice, and a test strip.

The Kloepfer '292 application discloses a meter for use in connectionwith the consolidated body fluid testing device (test wand) disclosed inthe '777 Kloepfer Publication. In addition to disclosing an inventivemeter, the Kloepfer '728 Publication also discloses improvements in thetest wand that facilitate its use with the meter.

Many of the improvements the Applicants and their colleagues have madeto test strips and test wands make them more useful for performing bloodtests from very small blood samples. Additionally, a transparent teststrip is used with the testing wand to permit the meter to detect bloodthrough transmittance photometry or reflectance photometry, rather thanbeing limited to the reflectance photometric methods used with currentmeters.

The meter disclosed in the Kloepfer et al., '728 Publication has manyfeatures in common with other meters, as it includes the commoncomponents of: (1) a receptacle for receiving a test strip; (2) aphotometry system, including a light source and receiver for performinga photometric analysis of a reagent-reacted blood samples toquantitatively determine the amount of a particular analyte of interest;(3) a processor within the meter to process the results obtained by thephotometric analysis to arrive at a quantitative value for the analyteof interest; and (4) a display for displaying the test results to theuser.

In summary, the three above-described Kloepfer references disclose animproved test strip and metering system that is believed by theApplicants to be more convenient to use than known systems, and that iscapable of being used with smaller samples than known devices.Nonetheless, room for improvement still exists.

For example, improvements can be made to the meter. Currently, mostmeters employed for measuring blood analytes are single analyte metersthat are useful only for performing the particular test for which theyare designed. Current meters could be improved by providing a singlemeter that is capable of performing a test simultaneously on a varietyof analytes. A particularly welcome improvement would be to provide atest strip and metering system that was capable of performing thesetests from a single blood sample.

One short coming of current meters is that since the single analytemeters are “stand alone” meters, they require their own processingcircuitry and/or software to perform many of their functions. Therefore,an improvement to this current situation would be to provide a meterthat is capable of utilizing the processing capability of a device, suchas a mobile phone, that most potential users already possess, and thatcontains the processing capability for performing many of the processingtasks currently performed by the meter, to thereby enable the user toreduce the number of devices that he must carry with him. Additionally,adding the meter components to the mobile device should be lessexpensive than the cost of manufacturing two separate devices.

Another area for potential improvement is to provide the meters with theability to communicate results to others, to a health provider, or tothe user's own computer for later retrieval and storage.

It is an object of the present invention to provide an improved bloodtesting system, that incorporates one or several of the improvementsdiscussed above.

III. SUMMARY OF THE INVENTION

In accordance with the present invention, an analyte testing device isdisclosed for use with a mobile processing device having a camera with alens, and a processor for processing an image captured by the camera.The analyte testing device comprises a casing and a test strippositioner. The test strip positioner positions an analyte containingtest strip adjacent to the camera lens to permit the camera to capturean image of the analyte containing test strip. A light source isdisposed within the casing. A light is positioned within the casing toilluminate the analyte containing test strip to facilitate the captureof the image of the test strip.

Processing software is provided for performing a quantitative analysisof at least one analyte from the captured image, and providing an outputof the results of the quantitative analysis.

Preferably, transmission software is also provided for transmitting atleast one of the captured images and quantitative analysis to the remotereceiver.

In a preferred embodiment of the present invention, the analytecontaining test strip includes an analyte receiving portion upon whichan analyte resides that has undergone a separation and a reaction with areagent. The camera captures an image of the analyte receiving portion.The analyte receiving portion can include a first analyte receivingportion containing a first analyte having undergone a first reactionwith a first reagent, and a second analyte receiving portion containinga second analyte having undergone a second reaction with a secondreagent. The camera is positioned to capture an image of the each of thefirst and second analyte portions, and the software within the mobileprocessing device is capable of performing a quantitative analysis oneach of the first and second analytes.

Also, the casing is preferably movably coupled to the mobile processingdevice between a testing position and a non-testing position. In thetesting position, the camera lens is aligned with a test strip portionto permit the camera to capture an image of the test strip.

In the non-testing position, the camera lens can capture an imagewithout interference from the casing, but during which time, the casingremains coupled to the mobile processing device. In the most preferredembodiment, the mobile processing device comprises a mobilecommunications device, such as a cell phone; and the casing is hingedlycoupled to the mobile communications device to move between the testingand non-testing position. Additionally, the casing can include a cavityfor storing a plurality of test strips therein.

The analyte testing device can either take the form of an externaldevice that includes a plug for being coupled to a data port of themobile processing device; or alternately, can be an internal device thatis encased within the housing of the mobile communication device, andthat is “hard wired” to the processor of the PD.

Preferably, the device includes a test strip port for receiving a teststrip on which the analyte of interest is contained. A light emittingdevice is provided for either illuminating the test field on which theanalyte is contained, or alternately, for projecting light onto the testfield. A miniaturized, digital camera, having a lens and image sensorsis provided for either receiving the transmitted light, or alternatelyphotographing the illuminated, analyte-containing test field. Thedigital camera can either comprise a “still” or motion picture typecamera. A motion picture type “video” camera would have the advantage ofpermitting the user to evaluate the process of the reaction and thekinetics of the test procedure.

In a preferred embodiment, the digital information received by theminiaturized digital camera is then directed to a processor forprocessing. The processor can comprise a processing unit containedwithin the analyte testing device. Alternately, the processor of themobile processing device can be employed to process the information. Themobile processing device's display is then employed to display an outputfrom the processor in a human readable form, so that the user may readthe information contained on the display to obtain a measurement of theanalyte of interest.

The test strip can be designed to permit the measurement of a pluralityof analytes simultaneously. Illustratively, a first reagent can beprovided for enabling the user to determine cholesterol level; a secondreagent provided for enabling the user to determine blood glucoselevels; and a third reagent provided to enable the user to determineblood lactate levels.

The test strip and digital camera can be designed to enable theminiaturized digital camera to receive photometric information abouteach of the plurality of reagents discreetly, so that the output of thedigital camera can provide discreet information to the processor abouteach of the analytes of interest, thus enabling the processor to providediscreet measurements for each of the three analytes withoutinterference from the presence of the other analytes on the test strip.

One feature of the present invention is that the test strip can bedesigned to employ a plurality of test strip fields where each teststrip field contains a reagent that is capable of reacting with adifferent analyte of interest to provide a colorimetric reactionproduct, whose color and intensity can be correlated with the quantityof the analyte in the test fluid. Preferably, these plurality of testfields and test results can be obtained through the application of asingle “micro” fluid sample, of about one to two microliters placed on asingle test strip.

This feature has the advantage of enabling the user to employ a teststrip to test for a variety of analytes.

This multiple test field approach has several advantages. One advantageis that the user can test for a plurality of analytes using a singletest strip and a single meter. To Applicants' knowledge,consumer-useable blood testing devices currently in use are singleanalyte devices, that are capable of testing only for a single analyte.As such, if the user wishes to test for three analytes, he must purchasethree separate test strips, and three separate meters.

Another important advantage resides in the ability of the user to testfor these plurality of samples by using only a very small blood sample.One draw back to patients who are performing self tests is the need toobtain blood samples. To obtain a blood sample, a user is required topierce a body part, such as a fingertip with a lancet. The blood thatbleeds from the tiny puncture hole is then placed onto a test strip.With the current invention, the user need only make one stick in onetissue site, and only obtain one blood sample, to test for multipleanalytes, thus reducing the potential number of times the user muststick himself.

Another feature of a preferred embodiment of the present invention isthat the testing device can be designed to be coupled to an existingmobile processing device such as a mobile communications device. Thisfeature has the advantage of reducing the number of devices that a usermust purchase and carry around with him.

At the time of the writing of this application, mobile processingdevices have become ubiquitous. Mobile processing devices can comprise awide variety of currently known products such as PDAs, cell phones, MP3players, lap top computers and the like.

Cell phones are especially ubiquitous. A large plurality of the adultpopulation in developed countries carry cell phones. Although small insize, cell phones contain a large amount of processing capability. Somecell phones, such as the Palm Treo 600 and Treo 300 mobile phonescontain a very large amount of processing capability, as the Treo modelsare personal digital assistants that include mobile telephonecapabilities. With the large amount of processing capacity available ina device that is already carried by most people, it seems somewhatwasteful to purchase a separate meter that contains its own processingsystem.

To reduce this duplication, the device of the present invention employsthe processing capability of the cell phone (or other mobile processingdevice). By making the testing device coupleable to a mobile phone, theuser can carry around only a single device (his mobile phone), ratherthan two or more devices, such as a mobile phone and testing meter.Additionally, by obviating the need for separate processing hardware andsoftware for the meter (as the phone's processing hardware and softwarecan be used), the meter can likely be manufactured less expensively,thus reducing the cost to the end user.

A further advantage provided by the use of a mobile processing devicethat includes a communication capability is that it permits the user tocommunicate his test results with others. For example, the user can usethe mobile phone to transmit his test results to a healthcare providerwho can then monitor the patient's test results, and thereby monitor thepatient's health. Additionally, the results can be transmitted from themobile phone to a user's computer, to enable the user to employ hiscomputer's large memory capability to archive his test results. Thetransmission can take the form of a text message, or graphic display,and can be forwarded as an e-mail type message.

A further feature of the present invention is that the test device isdesigned to use reagents that produce calorimetric reactions. This useof calorimetric reagents has several advantages. One advantage is thatthe colorimetric reagents, when used on a clear test field, permit theuse of transmittance photometry to measure the color produced in thereaction product to thereby quantify the amount of the analyte ofinterest in the test samples.

Another advantage obtained through the use of a colorimetric measurementis that it permits the user to visually see the results, therebypermitting the user to make a visual reliability check on the accuracyof the device.

A further advantage obtained by the colorimetric reaction is that itprovides a color-containing image of which a photograph can be taken bya miniaturized digital camera contained within the device. This digitalimage can be used for archival purposes. Alternately, the digitalinformation contained from the digital “photograph” can be employed asthe information that is processed by the processor of the mobileprocessing device to obtain the quantitative analysis of the analyte ofinterest.

These and other features and advantages of the present invention willbecome apparent to those skilled in the art upon a review of thedrawings and detailed description of the preferred embodiment of thepresent invention provided herein that represent the best mode ofpracticing the invention perceived presently by the Applicants.

III. BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective, exploded view of the body fluid testing systemof the present invention;

FIG. 2 is a top view of the system;

FIG. 3 is an enlarged, top view of the system;

FIG. 4 is an enlarged, perspective view, partly broken away, of a teststrip containing test wand useable with the present invention;

FIG. 5 is a top view of the system of the present invention showing aplurality of test wands coupled thereto;

FIG. 6 is a top, greatly enlarged schematic view of a test strip useablewith a test wand of the present invention;

FIG. 7 is a schematic view of the test strip, light source, and digitalcamera components of the present invention;

FIG. 8 is a perspective view, with the case of the meter componenttesting system partly broken away;

FIG. 9 is a perspective view, with a case of the meter component testingsystem removed;

FIG. 10 is an enlarged, somewhat schematic top view, showing a test wandinserted into a strip receiver of the test system of the presentinvention;

FIG. 11 is another top view, partly broken away of the presentinvention;

FIG. 12 is a perspective view of an alternate embodiment device;

FIG. 13 is a top, exploded view showing an alternate embodiment deviceuseable with an alternate embodiment MPD, and a test wand;

FIG. 14 is a perspective view of a second alternate embodiment of thepresent invention showing a device with a two-part clamshell like case;

FIG. 15 is a front view of the device;

FIG. 16 is a side view of the device showing the case in its openposition;

FIG. 17 is a perspective view of the device showing the case in an openposition;

FIG. 18 is another perspective view, showing the case in an openposition from a different view point;

FIG. 19 is a side view, partly in section of the device showing the casein the closed position;

FIG. 20 is an exploded perspective view of the device and a test one ofthe present invention;

FIG. 21 is a front perspective view of another alternate embodiment ofthe present invention that employs an optical path diameter that permitsan image of a test strip to be captured, even though the test strippositioner positions the test strip out of the normal optical path ofthe camera lens;

FIG. 22 is a front perspective view of the embodiment of FIG. 21 whereinthe camera face is “closed” to hide the number buttons; and

FIG. 23 is a side, schematic view of the alternate embodiment shown inFIG. 21.

IV. DETAILED DESCRIPTION

A body fluid testing system 8 of the present invention is shown in thefigures, as being comprised of three primary components. These threecomponents include a body fluid testing analytic unit 10, that iscapable of being operatively coupled to mobile processing device, andpreferably a mobile communications device, here shown as a mobiletelephone 12. The third primary component is a test strip containingtest wand 14 that is similar or identical to the ones disclosed in theKloepfer et al., '777 Publication, and/or the Kloepfer et al., '728publication, and which includes a test strip similar to the onesdisclosed in the Kloepfer '240 patent. The disclosures of these twoapplications and patent are hereby incorporated by reference into thisapplication.

The most common mobile processing device with which the system 8 willlikely be used are mobile communications devices such as mobile phones.The system 8 will likely be used with mobile phones 12 because mobilephone currently have three attributes that contribute to the viabilityof the present invention. The first attribute is that they generallyhave fairly robust processors that, through programming (such as byloading software into them), can be made to be capable of processinginformation received from the analytic unit 10 to create a user-readableoutput. Some mobile phones currently in use contain a very high level ofprocessing capability, and are currently both capable of beingprogrammed, and performing functions far beyond the typical conversationtransmission functions performed by cellular phones. For example, thePalm® Treo® 300, and 600 models comprise personal data assistants, thatalso include a mobile phone component.

The recently released Palm Treo 700 W has special utility as it iscapable of running Microsoft® Windows® mobile applications. Devices suchas the Palm Treo 600, 650 and 700 also are equipped with a significantamount of memory, e.g. 64 meg, that can be expanded drastically throughthe addition of a flash memory card into the already-existing socketprovided for receiving same.

Personal data assistants have many of the same functionalities ascomputers, possessing the ability to run programs, display information,perform calculations and the like. Additionally, other currentlyexisting cell phones have camera capabilities, and thereby theprocessing capability to process digital picture information, along withthe ability to transmit that digital picture information.

The mobile phone 12 includes a housing 18 that encases the electroniccomponents of the mobile phone 12. The housing 18 includes a frontsurface 20, a first side surface 22, and second side surface 24, a first(top) end surface 26, and a second (bottom) end surface 28. The frontsurface 20 includes a plurality (usually twelve) of number buttons 32,that the user presses for dialing a phone number, and a plurality offunction buttons 34 that the user may push in some predeterminedsequence to access and perform the various functions of which the phone12 is capable of performing. A main function button that can be designedto be a navigator button 36 is disposed between the function buttons 34of the device shown in the drawing.

An LCD display 30 is also disposed on the front surface 20, and iscapable of displaying a significant amount of information. In mobilephone/PDAs, the LCD displays can be quite large (e.g. four squareinches), and be capable of displaying a significant amount ofinformation. Optionally, the LCD display 38 may comprise a touch screenthat aids the user in navigating through menus and performing thevarious functions of which the phone 12 is capable. Although notnecessary with the present device, a touch-screen type LCD 38 ispreferably used, as it facilitates the operation of the device by theuser.

A data transfer port 42 is disposed on the bottom end surface 28. A widevariety of data transfer ports exist for use in connection with currentPDs. Many of the ports are used not only for transferring data betweenthe device and another device (such as a computer), but are also used tocarry voltage and current into the device to recharge the batteries ofthe mobile phone 12.

The testing device/analytic unit 10 includes a case 46, that includes acradle portion 48 and a component-containing lower portion 50. Thecradle portion 48 is designed to grip and hold the mobile phone 12 tocouple the analytic unit 10 to the phone 12. The casing 46 is preferablymade from a plastic material and may be constructed as a “clamshell”having two halves connected with a living hinge. The edges of the casingcan then be either permanently bonded together through sonic welding(after the components are inserted), or can be held together with aremovable fastener such as screws, so that the user may separate the twocasing halves, if necessary, to perform servicing of the electroniccomponents contained therein.

The cradle portion 48 includes a rear support member 52 that isplaceable adjacent to the rear surface of the housing of the phone 12; afirst side support member 54 that is provided for gripping the firstside surface 22 of the housing 18 of the phone 12; and a second sidesupport 56 for gripping the second side surface 28 of the housing 18 ofthe phone 12. Each of the first and second side supports 54, 56 caninclude a longitudinally extending clip rail 58. As is best shown inFIG. 3, clip rail 58 is provided for enabling a corresponding clip onthe test wands 14A-14D to grip the clip rail 58. Through this ability ofthe test wand 14 to grip on to the clip rail 58, the user can carryaround a plurality of test wands 14A-14D on his mobile phones Thisability to carry a plurality of test wands 14A-14D is important topersons who are either traveling and must carry several test wands 14with them, or those who must test their blood multiple times on a dailybasis.

The component containing portion 50 of the analytic unit 10 includes anupper surface containing a plurality of operation buttons, includingfunction button 70, and a main or navigator button 72. By pressing oneor a combination of the function 70 and navigator 72 buttons, the usercan direct the operation of the device. The casing 46 of the analyticunit 10 also includes a phone engaging first end surface 74 that isdesigned for engaging the bottom end surface 28 of the phone 12. Anaxially extending plug 76 extends axially outwardly from the phoneengaging first end surface 74 and is designed and configured to engagethe data port 42 of the phone 12. The casing 46 also includes a wandengaging second end surface 80 that includes a test wand receiving port82.

Test wand receiving port 82 is sized and configured for receiving andappropriately positioning the test strip 84 (FIG. 4) that is coupled toa test strip holder 86 that is formed as a part of the test wand 14. Thetest wand receiving port 82 serves as a test strip positioner that isdesigned to receive a test strip 84 in a proper orientation, to helpensure that the test strip 84 is inserted properly into the meter 12.The test strip 84 is properly oriented into the analytic unit 10 when amajor plane of the test strip 84 is generally perpendicular to the planeof the upper surface 68 of the meter 10, so that the camera of thedevice can capture an image of the analyte containing portion of thetest strip 84.

As best shown in FIG. 4, the test strip 84 is disposed at the end of atest wand 14, and includes an analyte receiving portion for receiving anappropriately separated body fluid that has reacted with an appropriatereagent. However, a hinge 90 hingedly couples a pressure cup 88 to thesame end of the test wand 14, so that when not in use, the pressure cup88 can cover the end of the test strip 84 to prevent contamination ordestruction of the test strip 84. The manner in which the pressure cup88 is used, and the test wand 14 is constructed, is discussed in moredetail in the Kloepfer '777 and '728 publications.

As is best shown in FIGS. 8-11, the components of the meter 12 include aprinted circuit board 100 that both serves as a base upon which othercomponents are placed, and also as a communication platform to enableelectronic communication between the various components. A strip take-upunit 102 is disposed centrally on the printed circuit board 100, and isprovided for receiving and properly orienting the test strip 84.

The strip take-up unit 102 includes an axially extending passageway 104,that receives the take-up test strip 84 and a portion of the test stripholder 86. The axially extending passageway 104 is configured to have avertical slot portion for properly orienting the test strip 84 withinthe test strip unit 102, so that the test strip 84 will be wellpositioned for the passage of light therethrough, to perform the testperformed by the meter. Preferably, the major plane of the test strip 84is disposed in a plane perpendicular to the direction of travel of thelight path.

A laterally extending passageway 108 is also provided. The laterallyextending passageway 108 extends generally perpendicular to the axiallyextending passageway 104, and intersects the axially extendingpassageway 104, so that the two passageways 104, 108 are incommunication with each other. The primary purpose of the laterallyextending passageway 108 is to provide a passageway for the light wavestraveling along light path 122, which light waves are emitted by thelight source, such as LED 114, and are received by the digital camera124.

The light source component of the analytic unit 10 includes light sourcecontrol circuitry 112 that is provided for controlling the operation ofthe light source 114. As discussed above, the light source 114preferably comprises an LED-type light. The LED light source 114 emitsbeams of light that travel through a spread glass or plate 120 disposedin the laterally extending passageway 104 for ensuring a uniform lightdistribution across the test strip 84.

A miniaturized digital camera 124 is provided for recording a digitalimage of the reagent reaction products on the test strip 84. The digitalcamera 124 includes an objective, such as lens 126, and an image sensorfor receiving the signals, along with signal processing software forprocessing signals into a digital picture. The image recorded by thedigital camera can be a “picture”, or can be signals representative ofthe light intensity, light wave length (“color”), or other parameteruseful for measuring the concentration of the analyte of interest withinthe reagent reaction product on the analyte receiving portion of thetest strip 84.

Similar to most digital cameras, the digital camera 124 of the presentinvention will likely employ charge-coupled devices (CCDs) for capturingthe image of the test strip. A CCD is a sensor for recording images thatis in digital photography and astronomy, and consists of an integratedcircuit containing an array of linked, or coupled, capacitors. Under thecontrol of an external circuit, each capacitor can transfer its electriccharge to one or other of its neighbors.

Digital color cameras generally use a Bayer mask over the CCD. Eachsquare of four pixels has one filtered red, one blue, and two green (thehuman eye is more sensitive to green than either red or blue). Theresult of this is that luminance information is collected at everypixel, but the color resolution is lower than the luminance resolution.Better color separation can be reached by three-CCD devices (3CCD) and adichroic beam splitter prism, that splits the image into red, green andblue components. Each of the three CCDs is arranged to respond to aparticular color. Some semi-professional digital video camcorders (andall professionals) use this technique.

The device 8 shown in the figures can operate through a transmissivemode, where the light transmitted by the LED 114 is transmitted in astraight line through the test strip to the video receptor 130 of thedigital camera 124. Alternately, the device can be designed to operatein a reflectance type mode, wherein the LED light source, test strips,and video receptor form an angled light path so that the video receptor(lens) captures an image of light emitted from the light source that isreflected off a surface of the test strip.

One of the important attributes of the light 114 and camera 124 used inthe analytic unit 10, is that they provide a controlled lightenvironment within the casing wherein a reproduceable and sufficientamount of light is shined upon the test strip 84. By containing thelight 114 and camera 124 components within a casing, interference fromoutside light sources, such as lights within a room, the sun, etc., canbe eliminated, thus helping to bolster the reproducibility and accuracyof the tests performed by the device.

Turning now to FIGS. 6 and 7, the test strip 84 includes a substratemember 138 having an upper surface 140, in which a sample travel path isformed. The sample travel path includes a sample receiving area 142,that is sized and positioned for receiving a drop of body fluid, such asblood, from the patient. As described in more detail in the Kloepfer etal. references described above, a capillary channel 146 is provided forseparating the plasma component of the blood from the cellularcomponents such as the red and white blood cells. The cells mustnormally be separated from the blood in order to obtain an appropriatecalorimetric reaction that does not contain interfering colors causedwith the colored components of the blood, such as the red and whiteblood cells.

The capillary channel includes a testing area 150 which comprises ananalyte receiving portion 150 upon which reagent strips 154, 156, 158are placed, and an excess collection area 148 that is disposeddownstream of the analyte receiving portion 150 for collecting excessfluids, to ensure that only a proper quantity of fluid remains in theanalyte receiving portion 150. As alluded to in this description, asample of blood is placed in a sample collection area 142, and flows ina direction designated by arrow BF, through the capillary portion 144,where the cellular components are retained. In the testing area, theplasma fluid reacts with the reagents placed on reagent strips 154, 156,158.

The first 154, second 156 and third 158 reagent strips each may containa different reagent for testing a different analyte of interest. Forexample, the first reagent 154 can be a reagent designed to elicit aquantitative colorimetric reaction from a first analyte of interest,such as blood glucose level. Similarly, the second reagent 156 can be areagent designed to detect the presence of a second analyte of interest,such as blood cholesterol, and the third reagent can be designed fordetecting a third analyte of interest such as blood lactate levels.

Alternately, each of the first, second and third reagent strips 154,156, 158 respectively, can be the same reagent for determining the sameanalyte of interest. In this case, three reagent strips may be used toprovide back ups to each other, or else permit the user to average thevalues determined by the colorimetric reaction produced by each of thethree reagents.

Although the test strip 84 is shown as having a first, second and third154, 156, 158 reagent strips, it will also be appreciated that more thanthree or less than three reagent strips can be used, to test a greateror lesser number of analytes of interest. Surprisingly, the Applicantshave found that the width of the reagent strip can be reduced to about 1mm., while still providing a sufficient area so that the digital cameraor other sensor will be able to pick up enough appropriate informationto provide reliable test strips.

It should also be noted that although the reagents are currently shownas being “reagent strips” 154, 156, 158, the shape and dimension of thereagent placements can vary. For example, the reagents' “strips” can bereplaced by a plurality of reagent “dots”.

An alternate embodiment blood testing system 200 is shown in FIGS. 12and 13. Testing system 200 is virtually identical to testing system 10.The main difference between the two is that the blood testing device204, has a different shaped casing, and different shaped data port plug210, to better fit the particular model of mobile phone 202 shown in thedrawings. It will also be noted that the casing of the testing device204 does not include the side rail structures or back support structureof the casing shown in FIGS. 1-11.

The blood testing device (analytic unit) 204 includes a top surface 208,that may or may not include a series of function buttons. The functionbuttons can be eliminated if the device is designed so that the act ofconnecting the plug 210 to the data receiving port 212 activates thephone 202 to recognize the analytic unit 204, and to display operationalinformation on the LCD screen. In such case, the operation of theanalytic unit 204 is controlled by the number button 216 and functionbuttons 218 of the cell phone. The blood test device 202 also includes awand receiving port 214 to receive the test strip 84 of test wand 14.

A second alternate embodiment clamshell—type blood testing device 300 isshown in FIG. 14-20. The testing device 300 includes a phone portion 302and an analytic unit portion 304. The phone portion 302 is hingedlycoupled to the casing 305 of the analytic unit portion 304 by a hinge306.

The phone portion 302 is generally similar to the mobile phonesdiscussed above, as it includes a front surface 307 having an LCDdisplay 310 thereon. The phone 302 also includes a plurality of numberbuttons 312 and one or more function buttons 314, which serve the samepurposes as in the embodiments discussed above. The phone portion 302also includes a rear surface 316. One element contained on phone portion302, which is not described with respect to the phones discussed aboveis a camera lens 320 that is contained on the rear surface 316. Thecamera lens 316 is of a type similar to those existing currently oncamera containing mobile phones. The lens 320 and built-in digitalcamera contained within the phone 302 are used on currently existingphones to enable the phone owner to use the cell phone user to takephotographs of friends, and whatever else she may desire.

One of the unique features of the embodiment of the device 300 shown inFIGS. 14-20, is that the lens 320 and camera contained within the phone302 are also usable by a body fluid test system for taking a “picture”of the analyte-containing test strip, to measure one or more analytes ofinterest that have been tested on the test strip.

As is best shown in FIG. 19, the lens 320 focuses light onto a photoreceptor 322 contained within the interior of the phone portion 302. Thephoto receptor 322 is coupled to image processing circuitry 324 that iscapable of processing the digital image received by the photo receptor322. As is discussed in more detail in connection with the embodimentsdescribed above, the “processing” component of the phone 302 cancomprise separate circuitry, or rely on the camera's or phone's alreadyexisting circuitry. Additionally, the processor of the phone 302 caninclude software that is runs on the processor of the phone 302 that canbe specifically adapted for performing the analyte test of the presentinvention.

As best shown in FIGS. 17 and 18, the phone portion case 302 includes alip 332 that is capable of engaging a lip 330 of the analytic unitportion case 304, so that the two portions can be placed a “closed” or“testing” position, as is shown in FIGS. 14, 19, and 20. A latch member(not shown) and release button (not shown) can be employed torespectively latch the two portions 302, 304 together, and release theengagement between the two portions 302, 304. When the release button isactuated to release the latch member, the phone portion 302 and analyticunit portion 304 can be moved about hinge 306 into an “open” or“non-testing” position, similar to that shown in FIGS. 16, 17 and 18.When the casing is in the non-testing or open position, the camera lens320 becomes unobstructed by the analytic unit portion 304 casing 305,thus enabling the camera to take a picture without interference from thecasing. In such a position, for example, a picture of a friend can betaken without the casing becoming a part of the picture.

The analytic unit portion 304 casing 305 includes a generally hollowinterior 338, a portion of which defines a wand storage compartment 340.As is shown in FIG. 17, a plurality of wands 14 can be stored in thewand storage compartment 340, to be ready for use when the user sodesires.

An objective 342 that includes a light output aperture 344, a lightsource 346 and a test strip holder 348 is disposed within the hollowinterior 338. The light output aperture 344 is positioned to be in anopposed relationship to the lens 320, so that the axis of the lightoutput aperture 344 is colinear with the axis of the lens 320 of thedigital camera within the phone 302 when the device 300 is in its closedposition.

The device also includes a test strip holder 348 which positions a teststrip (e.g. 84) properly in the light path LP when a test wand 14containing a test strip is inserted into the test wand receiving port350 that is formed on a side surface of the meter portion case 304. Asis best shown in FIG. 19, the light source 346, which may be an LED,shines the light upwardly through a test strip held within the teststrip holder 348. This projects the image of the color formed by theanalyte reaction products on the strip through the light output aperture344, through lens 320, and onto the photo receptor 322 of the digitalcamera contained within the phone 302. This information is thenprocessed by the phone's circuitry and software, into information thatultimately takes the form of information relating to the existence orquantity of the analyte of interest. This information is displayed onthe LCD screen 310 of the phone portion 302. The information, along withthe image, can also be saved as a file which can then be sent, as ane-mail or “test message” to another device, such as a computer used by ahealthcare provider.

A third alternate embodiment analyte testing device 400 is shown inFIGS. 21-23. The testing device 400 includes a phone portion 402 and ananalytic unit portion 404. The phone portion 402 is coupled to thecasing 405 of the analytic unit portion 404.

The phone portion 402 is generally similar to the mobile phonesdiscussed above, as it includes a front surface 407 having an LCDdisplay 410 thereon. The phone 402 also includes a plurality of numberbuttons 412 and one or more function buttons 414, which serve the samepurposes as in the embodiments discussed above. The phone portion 402also includes a rear surface 416. Similar to phone portion 302, phoneportion 402 includes a camera lens 420 that is contained on the rearsurface 416. The camera lens 420 is of a type similar to those existingcurrently on camera containing mobile phones. The lens 420 and built-indigital camera contained within the phone 402 are used on currentlyexisting phones to enable the phone owner to use the cell phone user totake photographs of friends, and whatever else she may desire.

Similar also to phone 302, the lens 420 and camera contained within thephone 402 are also usable by a body fluid test system for taking a“picture” of the analyte-containing test strip 421, to measure one ormore analytes of interest that have been tested on the test strip.

Another difference between device 400 and device 300, is that device 400includes an optical unit 422, that includes a test positioner 424, thatplaces the test strip 421 in a position that is out of the normaloptical path. As will be appreciated, the normal optical path of a lensis the area directly in front of a lens. The optical unit 422 includesan optical path diverter 426 for diverting the light path 436 to teststrip 421. The optical path diverter 426 includes a first mirror 428disposed at a 45° angle to the light path for reflecting light at a 90°angle, from a generally “vertically” directed path (as shown in FIG. 23)to a “horizontally” directed path, that enables the light path to passthrough the camera lens 420. Additionally, the optical path diverter 426includes a first lens, for focusing the light path and the image showntherethrough.

The optical unit 422 of the analytic unit 404 includes a light source434, such as an LED, that emits the light along a light path 436. Thelight passes through the test strip 421 that is held in the test strippositioner 424. Light emerging from the test strip 421 (that is passedtherethrough) passes through a lens 430, where it is focused. The lightpath 436 continues to extend to reflecting mirror 428, where the lightpath is reflected at a 90 degree angle, so that the light can passthrough the lens 420 of the camera. Light that passes through the lens420 is captured by the CCD chip 440 of the digital camera. The image socaptured is then conducted to a processor 442.

The processor 442 includes the image processing software, for processingthe image. Additionally, the software is capable of processing the imagecaptured by the CCD chip 440, to provide a quantitative analysis of theanalyte contained on the analyte receiving portion of the test strip421. The processor 442 can then transfer the data to the transmitterportion 446 of the cell phone, which itself includes software thatpermits the image and the quantitative analysis to be transmitted, ifdesired to a remote source, such as to another computer, another cellphone or to an appropriate storage device.

Having described the above invention in reference to the presentlyperceived best mode of practicing the invention, it will be appreciatedthat variations and modifications exist that fall within the spirit ofthe invention.

1. An analyte testing apparatus for providing a quantitative analysis ofan analyte of a body fluid placed on an analyte containing test strip,the analyte testing apparatus comprising: a mobile telephone containingmobile processing device having a digital camera capable of capturing aphotographic image of an analyte containing test strip, the digitalcamera including a lens, the mobile processing device including softwareoperable by the mobile processing device for processing the photographicimage captured by the camera to yield an output comprising aquantitative analysis of an analyte on a test strip, and an analytetesting device comprising a casing configured for being coupled to themobile telephone, the casing including a test strip positionerconfigured for positioning an analyte containing test strip in aposition wherein the camera lens of the mobile telephone is positionedfor capturing the photographic image of an analyte containing teststrip; and a light source configured and positioned for illuminating ananalyte containing test strip to facilitate the capture of thephotographic image of an analyte containing test strip taken by thedigital camera of the mobile telephone.
 2. The analyte testing apparatusof claim 1 further comprising an analyte containing test strip, whereinthe analyte containing test strip includes at least one of a first and asecond reagent, a first analyte receiving portion containing a firstanalyte comprising a first body fluid fraction that has undergone afirst reaction, and a second analyte receiving portion containing asecond analyte comprising a second body fluid fraction that hasundergone a second reaction with the second reagent.
 3. The analytetesting apparatus of claim 1 further comprising a test strip, andwherein the casing is hingedly coupled to the mobile processing deviceand is configured for being movable between a testing position whereinthe digital camera lens is aligned with the test strip positioner topermit the camera to capture an image of the test strip, and anon-testing position wherein the digital camera lens can capture animage of an object other than that of the test strip withoutinterference from the casing, but wherein the casing remains coupled tothe mobile processing device between the testing position and thenon-testing position.
 4. The analyte testing system of claim 1 whereinthe casing comprises an integral casing.
 5. An analyte testing apparatusfor providing a quantitative analysis of an analyte of a body fluidcomprising a mobile telephone containing a mobile processing deviceincluding a digital camera having a lens for capturing a digitalphotographic image on an item in an optical path of the lens, the mobileprocessing device including software for performing a quantitativeanalysis on an analyte of a body fluid and providing an output of aresult of the quantitative analysis, a test wand including a housing, atest strip for receiving an analyte of a body fluid, and a test stripholder for holding the test strip on to the housing, and a positionerfor coupling the test wand to the mobile telephone wherein the analyteof the body fluid on the test strip is positioned in the optical path ofthe lens of the digital camera so that the digital camera of the mobiletelephone is positioned for capturing a digital photographic image ofthe analyte, so that the image so captured may then be processed by thesoftware for performing a quantitative analysis by the mobile processorto perform the quantitative analysis.
 6. The analyte testing apparatusof claim 5 further comprising transmission software loadable into themobile processing device the transmission software configured fortelephonically transmitting both of the captured digital images and theresult of the quantitative analysis to a remote receiver.
 7. The analytetesting apparatus of claim 5 wherein the casing has an interior, thecasing being configured for enclosing the lens of the digital camera andthe light source to provide a controlled light environment within thecasing interior.
 8. The analyte testing apparatus of claim 7 furthercomprising an analyte containing test strip, wherein the light source,test strip and camera lens are configured to be positioned to define alinear light path wherein the light source shines its light through thetest strips and into the camera lens.
 9. The analyte testing apparatusof claim 7 further comprising an analyte containing test strip whereinthe light source, test strip and camera lens are configured to bepositioned to define an angled light path wherein the lens captures animage of light emitted from the light source that is reflected off of asurface of the test strip.
 10. The analyte testing apparatus of claim 5further comprising a first reagent and wherein the analyte receivingportion includes a first analyte receiving portion containing a firstanalyte comprising a first body fluid fraction that has undergone afirst reaction, and a second analyte receiving portion containing asecond analyte comprising a second body fluid fraction that hasundergone a second reaction with a second reagent.
 11. The analytetesting apparatus system of claim 10 further comprising a third reagent,wherein the analyte receiving portion further includes a third analytereceiving portion and a third analyte resident on the third analytereceiving portion, the third analyte comprising a third body fluidfraction that has undergone a third reaction with the third reagent. 12.The analyte testing apparatus of claim 11 wherein the first analytecomprises a body fluid and the reagent comprises a reagent useful fordetermining blood glucose levels, the second analyte comprises a bodyfluid and second reagent, the second, reagent being useful fordetermining blood cholesterol levels, and the third analyte comprises abody fluid and third reagent, the third reagent being useful fordetermining blood lactate levels.
 13. The analyte testing apparatus ofclaim 5 further comprising a casing that includes a cavity configuredfor storing a plurality of test strips therein.
 14. The analyte testingapparatus of claim 5 further comprising a casing configured to becoupled to the mobile processing device wherein at least one of the lensand casing are movable into a position wherein the lens of the camera ispositioned for capturing images of objects other than of the test stripwithout interference from the casing.
 15. The analyte testing apparatusof claim 14 wherein the casing is configured to be movable between atesting position wherein the camera lens is aligned with the positionerto permit the camera to capture an image of the analyte on the teststrip; and a non-testing position wherein the lens of the camera ispositioned to capture an image of objects other than that of the teststrip without interference from the casing, but between the twopositions the casing remains coupled to the mobile processing device andwherein the casing includes a cavity for storing a plurality of teststrips therein.
 16. The analyte testing apparatus of claim 5 furthercomprising a casing that includes a cavity configured for storing aplurality of test strips therein, and wherein the test strip includes areagent, an analyte receiving portion, and an analyte resident upon theanalyte receiving portion, the analyte including a body fluid that hasundergone a separation and a reaction with the reagent, wherein thereagent comprises a first reagent and a second reagent, wherein theanalyte receiving portion includes a first analyte receiving portioncontaining a first body fluid fraction that has undergone a separationand a reaction with the first reagent, and a second analyte receivingportion containing a second body fluid fraction that has undergone aseparation and a reaction with the second reagent, wherein the digitalcamera is configured to captures an image of the first and secondanalyte receiving portions; and wherein the software contained withinthe mobile telephone containing mobile processing device is configuredfor performing a quantitative analysis of each of the first and secondseparated and reacted body fluid fractions.
 17. The analyte testingsystem of claim 16 wherein the reagent comprises a first reagent and asecond reagent, wherein the analyte receiving portion includes a firstanalyte receiving portion containing a first body fluid fraction thathas undergone a separation and a reaction with the first reagent, and asecond analyte receiving portion containing a second body fluid fractionthat has undergone a separation and a reaction with the second reagent,wherein the camera is configured to capture an image of the first andsecond analyte receiving portions; and wherein the software containedwithin the mobile processing device is configured for performing aquantitative analysis of each of the first and second separated andreacted body fluid fractions.
 18. The analyte testing apparatus of claim5 further comprising a light source configured and positioned forilluminating the analyte containing test strip to illuminate the teststrip to facilitate the capture of the photographic image of the ananalyte containing test strip taken by a digital camera of the mobiletelephone.
 19. An analyte testing apparatus for providing a quantitativeanalysis of an analyte of a body fluid placed on an analyte containingtest strip, the analyte testing apparatus comprising: a mobile telephonecontaining a mobile processing device having a digital camera capable ofcapturing a photographic image of an analyte containing test strip, thedigital camera including a lens, the mobile processing device includingsoftware operable by the mobile processing device for processing aphotographic image captured by the camera to yield an output comprisinga quantitative analysis of an analyte on a test strip, a test wandincluding a housing, a test strip for receiving an analyte of a bodyfluid, and a test strip holder for holding the test strip on to thehousing, and a positioner for coupling the test wand to the mobiletelephone wherein the analyte of the body fluid on the test strip ispositioned in the optical path of the lens of the digital camera so thatthe digital camera is positioned for capturing a digital photographicimage of the analyte, so that the image so captured can be processed bythe software to perform the quantitative analysis.
 20. The analytetesting system of claim 19 further comprising a casing that includes aphone receiving portion configured for detachably coupling the casing tothe mobile phone containing mobile processing device.
 21. The analytetesting apparatus of claim 19, wherein the test strip positionerpositions the test strip in a position out of an undiverted optical pathof the lens of the digital camera, and wherein the casing includes anoptical path diverter between the lens and the test strip for permittingthe camera to capture an image of the analyte containing test strip. 22.The analyte testing apparatus of claim 21 wherein the optical pathdiverter comprises at least one mirror for reflecting an image of theanalyte containing test strip into the lens.